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Clozapine is an efficacious antipsychotic drug for patients with treatment-resistant schizophrenia, but does not sufficiently improve these symptoms in a substantial proportion of this population. There is no convincing evidence for the efficacy of any clozapine augmentation strategy. New evidence suggests that glutamate receptors are a candidate target for therapeutic effects in schizophrenia. We present an overview of studies assessing the potential clinical utility of adding glutamatergic agents to clozapine. We conducted 3 metaanalyses of data on positive, negative and overall symptoms of schizophrenia, analysing results from 3 studies on clozapine augmentation with glycine, 6 studies on lamotrigine add-on therapy to clozapine and 4 studies on topiramate addition to clozapine.
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One year, open-label, flexible-dosing clinical trial.
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Anticonvulsant drugs have multiple mechanisms of action. Recent in vivo MRS studies suggest that cerebral gamma-aminobutyric acid (GABA) increases occur with the administration of certain anticonvulsants in humans.
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In conclusion, in this study Topamax (reference product) and Sincronil (generic formulation) have proven therapeutically equivalent and both products were well tolerated.
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Significant advances have been made in the understanding of the pathophysiology, genetics and therapy of tremor disorders during the last 12 months. This review will consider Parkinson disease, essential tremor and other tremors and highlight advances in the field.
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Compare the pharmacokinetic (PK) profiles of immediate- and extended-release formulations of topiramate (TPM) in healthy subjects following multiple dosing, and evaluate maintenance of topiramate exposures after switching formulations.
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Migraine is a costly, recurrent condition that affects 28 million individuals in the United States yet remains underdiagnosed and undertreated. In 2004, the U.S. Food and Drug Administration approved topiramate for the prevention of migraine in adults, joining three other agents with this indication: divalproex sodium, propranolol, and timolol. We evaluated the role of topiramate in the treatment of migraine based on published literature and our clinical experiences. A qualitative systematic search of the literature from January 1966-December 2004 was conducted by using MEDLINE, and other pertinent literature was reviewed. Three large, randomized, placebo-controlled trials of topiramate for migraine prevention in individuals experiencing 3-12 attacks/month have been published, as have several small studies and a comparator trial with propranolol. Based on the results of these studies, 100 mg/day is the optimum topiramate dosage in terms of efficacy and tolerability. Using that dosage, the number of migraine attacks/month decreased by approximately two. Several other secondary outcome measures were also significantly reduced including the number of days/month with migraine and the use of acute treatment/attack. Suboptimal efficacy was shown with 50 mg/day, whereas 200 mg/day caused considerably more tolerability issues. Paresthesia was dose related and the most common cause of attrition. Cognitive dysfunction and weight loss were also commonly reported. The reduction by two migraines/month demonstrated with topiramate in clinical trials is similar to the published results for other preventive agents, though most of those studies were small, antiquated, and poorly designed. In contrast, the topiramate trials enrolled a larger number of patients and closely adhered to the International Headache Society research recommendations, strengthening the quality of results. Topiramate 100 mg/day is an effective option in adults who require migraine prophylaxis. Although the published efficacy results of the various migraine preventive agents are comparable, the superior study design of the topiramate trials warrants consideration of topiramate as an agent of choice for migraine prevention. Future studies of any preventive agent should include more refined quality-of-life outcomes.
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Occurrence of generalized tonic-clonic seizures (GTCS) is one of the most important risk factors of seizure-related complications and comorbidities in patients with epilepsy. Their prevention is therefore an important aspect of therapeutic management both in idiopathic generalized epilepsies and in focal epilepsies.
We report a case a carbamazepine (CBZ) intoxication with negative myoclonus that occurred 4 weeks after clobazam (CLB) had been added to a stable regimen of CBZ and topiramate (TPM). Both CBZ and CBZ-epoxide (CBZ-E) blood levels were elevated, and the symptoms resolved quickly when CBZ dosage was reduced and CLB discontinued. CLB was reintroduced a year later with the patient's consent, and the time course of the interaction was studied: CBZ and CBZ-E levels increased slowly over 12 days. The interaction is thus probably related to the progressive increase in Nor-CLB.
Our findings support recent data regarding choices of medication in the pediatric population and additionally support current studies and future investigation into controlled trials in the pediatric population.
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This randomized, open-label, five-group study included two 28-day cycles. Five groups of female subjects received oral doses of ORTHO-NOVUM 1/35 alone (cycle 1) and then concomitant with TPM or CBZ (cycle 2). The treatment groups were group 1, TPM, 50 mg/day; group 2, TPM, 100 mg/day; group 3, TPM, 200 mg/day; group 4, TPM, 200 mg/day (obese women); and group 5, CBZ, 600 mg/day. Group 4 comprised obese women whose body mass index (BMI) was between 30 and 35 kg/m(2). The BMI of the remaining four groups was < or =27 kg/m2.
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Data of 246 patients with epilepsy admitted to our Department during the year 2001 were retrospectively analyzed.
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The present study was undertaken to develop an animal model exploiting food cue-induced increased motivation to obtain food under operant self-administration conditions. To demonstrate the predictive validity of the model, rimonabant, fluoxetine, sibutramine and topiramate, administered 1 hour before the experiment, were tested. For 5 days, female Wistar rats were trained to self-administer standard 45 mg food pellets in one daily session (30 minutes) under FR1 (fixed ratio 1) schedule of reinforcement. Rats were then trained to an FR3 schedule and finally divided into two groups. The first group (control) was subjected to a standard 30 minutes FR3 food self-administration session. The second group was exposed to five presentations of levers and light for 10 seconds each (every 3 minutes in 15 minutes total). At the completion of this pre-session phase, a normal 30-minute session (as in the control group) started. Results showed that pre-exposure to environmental stimuli associated to food deliveries increased response for food when the session started. Corticosterone and adrenocorticotropic hormone plasma levels, measured after the 15-minute pre-exposure, were also significantly increased. No changes were observed for the other measured hormones (growth hormone, prolactin, thyroid-stimulating hormone, luteinizing hormone, insulin, amylin, gastric inhibitor polypeptide, ghrelin, leptin, peptide YY and pancreatic polypeptide). Rimonabant, sibutramine and fluoxetine significantly reduced food intake in both animals pre-exposed and in those not pre-exposed to food-associated cues. Topiramate selectively reduced feeding only in pre-exposed rats. The present study describes the development of a new animal model to investigate cue-induced increased motivation to obtain food. This model shows face and predictive validity, thus, supporting its usefulness in the investigation of new potential treatments of binge-related eating disorders. In addition, the present findings confirm that topiramate may represent an important pharmacotherapeutic approach to binge-related eating.
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Dravet syndrome is a severe infantile onset epileptic encephalopathy associated with mutations in the sodium channel alpha 1 subunit gene SCN1A. To date no large studies have systematically examined the prognostic, clinical and demographic features of the disease. We prospectively collected data on a UK cohort of individuals with Dravet syndrome during a 5-year study period and analysed demographic information based on UK population and birth figures. From structured referral data we examined a range of clinical characteristics including epilepsy phenotype, seizure precipitants, electroencephalography data, imaging studies, mutation class and response to medication. Predictors of developmental outcome were determined by logistic regression. We identified 241 cases with SCN1A mutation-positive Dravet syndrome, 207 of which were UK-based. The incidence of mutation-positive Dravet syndrome is at least 1:40 900 UK births. Clinical features predicting a worse developmental outcome included status epilepticus (odds ratio = 3.1; confidence interval = 1.5-6.3; P = 0.003), interictal electroencephalography abnormalities in the first year of life (odds ratio = 5.7; confidence interval = 1.9-16.8; P = 0.002) and motor disorder (odds ratio = 3.3; confidence interval = 1.7-6.4; P < 0.001). No significant effect was seen for seizure precipitants, magnetic resonance imaging abnormalities or mutation class (truncating versus missense). Abnormal magnetic resonance imaging was documented in 11% of cases, principally with findings of non-specific brain atrophy or hippocampal changes. Sodium valproate, benzodiazepines and topiramate were reported as being the most helpful medications at the time of referral. Aggravation of seizures was reported for carbamazepine and lamotrigine. The identification of factors influencing prognosis both aids counselling and encourages early, syndrome-specific therapy. Prevention of status epilepticus with regular medication and emergency protocols is important and may influence developmental outcome.
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The safety population consisted of all patients who took >or=1 dose of study medication during the double-blind phase (topiramate 50 mg/day [N = 235], 100 mg/day [N = 386], 200 mg/day [N = 514], or placebo [N = 445]). Safety assessments included adverse event (AE) reports, physical examination, and clinical laboratory tests.
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Cardiac arrhythmia may be one of the major causes of sudden unexpected death in children with epilepsy. We assessed drug-induced QT prolongation to establish whether the use of antiepileptic drugs contributes to sudden unexpected death. A total of 178 children with epilepsy (93 males and 85 females, with ages ranging from 1 month to 18.9 years; mean age 7.0 +/- 4.1 years) were involved in the study. The QT intervals were manually measured and corrected using Fridericia's formula (QTFc = QT/RR(1/3)). The mean corrected QT interval (QTc) of 152 children on antiepileptic drugs during the study period was 0.40 +/- 0.03 s, and for 26 age-matched, antiepileptic drug-free control patients it was 0.40 +/- 0.03 s. The mean QTc of the children with monotherapy was 0.40 +/- 0.03 s for the valproate group (n = 42), 0.39 +/- 0.02 s for the carbamazepine/oxcarbazepine group (n = 34), and 0.40 +/- 0.02 s for the topiramate group (n = 26), respectively. There was no statistically significant difference among the groups as assessed by analysis of variance. In addition, there was no significant difference between the monotherapy group (n = 109; 0.40 +/- 0.02 s) and the polytherapy group (n = 43; 0.39 +/- 0.03 s). Major antiepileptic drugs may not precipitate prolongation of the QT interval into sudden unexpected death in children with epilepsy, however further studies are required.
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Rapid cycling bipolar disorder (RCBD) is defined in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) as a type of manic-depressive illness in which the patient experiences four or more episodes of mania and/or major depression per year. It was first reported as a consequence of the reduced effectiveness of lithium carbonate in the treatment and prophylaxis of this form of bipolar disorder (BD) in contrast to those with less frequent cycling. Among the anticonvulsants, there have been reports with different degrees of controlled data concerning carbamazepine, valproate, lamotrigine, topiramate, gabapentin and primidone. There is a paucity of double-blind studies, but what is available supports the use of lamotrigine. There is open data supporting the use of carbamazepine, valproate and topiramate. Regarding other classes, nimodipine may have specific utility in ultradian- (ultra-ultra-) or ultra-RCBD and there is double-blind data regarding the specific utility of olanzapine in RCBD. Low thyroid function may be a factor in development of RCBD; therapies aimed at elevating thyroid levels, even beyond the usual range, have frequently produced benefits in open trials. More research is needed into the possible therapeutic benefits of verapamil, bupropion, choline, light therapy and electroconvulsive therapy (ECT).
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Some patients experience cognitive disturbances with topiramate.
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We performed a literature review of the research findings related to treatment-resistant BD reported through February 2012.
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Topiramate, propranolol and divalproex may be more efficacious than other prophylactic medications. Besides, the safety and tolerability of divalproex should be further verified by future studies.
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In pediatric epilepsy, neurodevelopmental comorbidities could be sometimes even more disabling than seizures themselves, therefore it is crucial for the clinicians to understand how to benefit these children, and to choose the proper antiepileptic drug for the treatment of epilepsy associated to a specific neurodevelopmental disorder. Aim of this paper is to discuss the potential impact on cognition and behavior of new and newest AEDs and to guide the choice of the clinicians for a targeted use in epilepsy associated with specific neurodevelopmental disorders.
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Brain free DA levels were significantly lower and plasma EAA levels were significantly higher in the TS model group compared with those in the blank control group (P<0.05). Topiramate of 10 and 20 mg/kg significantly decreased the frequency of IDPN-induced HTR and significantly increased the level of brain free DA when compared with the TS model group (P<0.05). Topiramate of 20 mg/kg treatment as haloperidol treatment significantly decreased plasma EAA levels compared with the TS model group (P<0.05).
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The available data suggest that the risk of developing renal calculi during zonisamide treatment is low. Data are insufficient to determine whether concomitant treatment with topiramate increases the risk of renal stones.
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The appropriate treatment of migraine requires an individually tailored approach and is based on bio-behavioral, nonpharmacological and pharmacological methods. The available data in the pertinent literature on pharmacologic approaches are few and contradictory. Drug approaches for migraine attack include acetaminophen, NSAIDs and triptans. Acetaminophen and ibuprofen are often effective, but some migraine attacks may be refractory. The triptans can be a useful therapeutic option in adolescents. The literature data on prophylaxis are conflicting: flunarizine and topiramate are probably effective; for other drugs (including cyproheptadine, amitriptyline, divalproate and levetiracetam) there is insufficient evidence in children. The results from the use of propranolol are conflicting, whereas nimodipine and clonidine have been shown to be noneffective. Further studies are needed based on larger samples, multicenter trials, patient selection from primary care centers, and precise respect of current international diagnostic criteria. Moreover, new parameters of treatment efficacy should be considered.
Placebo response in clinical trials for anti-epileptic drugs (AEDs) has been examined and a recent meta-analysis revealed that East Asian trials showed unexpectedly higher placebo response. As multi-national trials have become common, it is important to understand placebo response in different settings, including regions/countries for future clinical trials.
Therapeutic hypothermia reduces mortality and neurologic impairment in neonates with hypoxic-ischemic encephalopathy. Topiramate exerts a neuroprotective effect in asphyxiated neonatal animal models. However, no studies have investigated the association of hypothermia and topiramate, because topiramate pharmacokinetics during hypothermia and the optimal administration schedule are unknown. The influence of hypothermia on topiramate pharmacokinetics was evaluated in asphyxiated neonates treated with prolonged whole-body hypothermia and topiramate.
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Treatment of manifestations: Benzodiazepines (particularly clonazepam) used to treat myoclonus-dystonia improve both myoclonus and tremor. Antiepileptic drugs (valproate, topiramate) may improve myoclonus, but the response is variable. Anticholinergic medication may improve dystonia; botulinum toxin injection may be especially helpful for cervical dystonia. Improvement with L-5-hydroxytryptophan, L-dopa and the salt of sodium oxybate has been reported. Stereotactic thalamotomy can improve myoclonus but has caused dysarthria and hemiparesis. Deep brain stimulation has improved both myoclonus and dystonia in several individuals; it is unclear whether targeting the globus pallidus interna (GPi) is more effective than targeting the ventral intermediate nucleus of the thalamus (VIM). Other: Symptoms of M-D often improve short term with ingestion of alcohol, but the risk of addiction recommends against its long term use.
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Vigabatrin, lamotrigine, topiramate, levetiracetam, oxcarbazepine, zonisamide, rufinamide, lacosamide, eslicarbazepine, and perampanel have been included in this review. The most tolerated AEDs from a cognitive and behavioral point of view are lamotrigine and rufinamide, thus representing optimal drugs for children with cognitive and/or attention problems.
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This 6-month open-label study evaluated the efficacy and safety of topiramate monotherapy for partial-onset or primarily generalized seizures in 22 adults with newly diagnosed epilepsy. The initial topiramate dose of 25 mg could be titrated to a maximum effective or maximum tolerated dose of 200 mg/d. Eighteen patients completed the study. The mean topiramate dose was 200 mg/d (range, 75-200 mg/d). Compared with baseline, monthly seizure frequency decreased 89% (median), with 17 patients (94%) achieving complete control. Five patients dropped out of the study. No changes in hematologic, renal, and hepatic function evaluations were noted, and only 1 patient experienced clinical signs significant enough to warrant discontinuation of treatment. In this small study, topiramate in doses ranging from 75 to 200 mg/d was effective and well tolerated as monotherapy in adults with newly diagnosed epilepsy.